Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study
| Autor: | Thasia G. Woodworth, Juan J. Gomez-Reino, Graeme Jones, Mark C. Genovese, Jieruo Gu, Matija Tomšič, Daniel Siri, Mitchell B. Lowenstein, Emma Alecock, Armando Calvo, Anthony Sebba |
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| Rok vydání: | 2009 |
| Předmět: |
musculoskeletal diseases
Adult Male medicine.medical_specialty Immunology Arthritis Sirukumab Placebo Antibodies Monoclonal Humanized Gastroenterology Severity of Illness Index General Biochemistry Genetics and Molecular Biology law.invention Arthritis Rheumatoid chemistry.chemical_compound Tocilizumab Rheumatology Randomized controlled trial Double-Blind Method law Internal medicine medicine Immunology and Allergy Humans skin and connective tissue diseases Aged business.industry Antibodies Monoclonal Middle Aged Clinical and Epidemiological Research medicine.disease Receptors Interleukin-6 Surgery C-Reactive Protein Methotrexate Treatment Outcome chemistry Rheumatoid arthritis Antirheumatic Agents Female business Biomarkers Immunosuppressive Agents medicine.drug |
| Zdroj: | Annals of the Rheumatic Diseases |
| ISSN: | 1468-2060 |
| Popis: | Background:The anti-interleukin (IL) 6 receptor antibody tocilizumab inhibits signalling of IL6, a key cytokine in rheumatoid arthritis (RA) pathogenesis.Objective:To evaluate through the AMBITION study the efficacy and safety of tocilizumab monotherapy versus methotrexate in patients with active RA for whom previous treatment with methotrexate/biological agents had not failed.Methods:This 24-week, double-blind, double-dummy, parallel-group study, randomised 673 patients to either tocilizumab 8 mg/kg every 4 weeks, or methotrexate, starting at 7.5 mg/week and titrated to 20 mg/week within 8 weeks, or placebo for 8 weeks followed by tocilizumab 8 mg/kg. The primary end point was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 24.Results:The intention-to-treat analysis demonstrated that tocilizumab was better than methotrexate treatment with a higher ACR20 response (69.9 vs 52.5%; p3×–Conclusion:Tocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit–risk, in patients for whom treatment with methotrexate or biological agents has not previously failed.Trial registration number:NCT00109408 |
| Databáze: | OpenAIRE |
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